Don't call me..., page-11

The FDA have determined that Bene's Zilosul must be used in all clinical trials. If/when approved, it will only be Bene's Zilosul which can be registered as treatment for the approved indications. Anyone trying to create a biosimilar will have to take it right through all the trials. They'll have to invest a decade and tens of millions of dollars, minimum, to have their biosimilar approved by the FDA. But the, why would they do this when they are not allowed to sell it in the US, the EU, and the other jurisdictions where PAR hold the patents for use of iPPS to treat these conditions?

I refer you to Page 2 of Bell Potter's report on PAR's intellectual property position, written after the original meetings with the FDA in the first Q of 2020. Many people think as you do when they hear that PAR has no production patent on the drug. However, understanding how PAR have overlaid sales/treatment patents with supply protection from the only approved iPPS DMF is key to realising what a uniquely fortified position they have claimed. Think how a competitor would arise, really think it through, as realising how difficult their pathway is really is the key to understanding what an incredible opportunity PAR have here.